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EN ISO 10993-18:2009 Standard



#device #assessment #material #equivalence #used


Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Friday 17th of November 2017


Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)


This part of ISO 10993 describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information generated can be used for a range of important applications, for example: - As part of an assessment of the overall biological safety of a medical device (ISO 10993-1 and 14971). - Measurement of the level of a leachable substance in a medical device in order to allow the assessment of compliance with the allowable limit derived for that substance from health based risk assessment (ISO 10993-17). - Judging equivalence of a proposed material to a clinically established material. - Judging equivalence of a final device to a prototype device to check the relevance of data on the latter to be used to support the assessment of the former. - Screening of potential new materials for suitability in a medical device for a proposed clinical application.


Friday 17th of November 2017


This standard superseed the "EN ISO 10993-18:2005".

Anyway is still possible use the "EN ISO 10993-18:2005" until March 21st, 2010

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